Treatment of Metastatic Breast Cancer as a Guide to Design of Adjuvant Therapy Trials

Author(s):  
Trevor J. Powles
2004 ◽  
Vol 90 (5) ◽  
pp. 962-967 ◽  
Author(s):  
A Gennari ◽  
P Bruzzi ◽  
C Orlandini ◽  
B Salvadori ◽  
S Donati ◽  
...  

Author(s):  
Ya A. Shliakhtunou

Abstract The aim To conduct a prospective randomized controlled study of the optimization of adjuvant therapy in patients with non-metastatic breast cancer, taking into account the presence of circulating tumor cells (CTCs) with an assessment of tumor-specific OS and DFS. Materials Stage 1 Continuous non-randomized prospective study (n = 102) to study the clinical and prognostic value of CTCs and evaluate the effectiveness of adjuvant systemic therapy in relation to CTC eradication; Stage 2 Prospective randomized controlled study (n = 128) of optimization of adjuvant therapy taking into account CTCs with an assessment of the effectiveness of the standard therapy and an optimized therapy regimen. Results Monitoring of CTCs during adjuvant drug treatment has established that a significant decrease in the frequency of CTC identification can be achieved only by sequential administration of anthracyclines and taxanes (paclitaxel) AC-T, which allows reducing CTCs compared to other regimens from 52.6 to 15.8% (p = 0.006). CTC-oriented personalized adjuvant therapy in the experimental group, based on the timely transition from an ineffective adjuvant chemotherapy regimen to taxanes, as well as additional monochemotherapy with gemcitabine can achieve 100% eradication CTCs. In the adjuvant therapy experimental group taking into account CTCs (n = 68), the OS 5-year tumor-specific rate was 90.3 ± 3.8%, (control group 78.7 ± 3.9%, p = 0.036). DFS tumor-specific in the experimental group was 88.0 ± 4.4%, (control group 80.6 ± 3.3%, p = 0.023). Conclusions The use of the method of treatment of CTC-oriented personalized adjuvant therapy for non-metastatic breast cancer makes it possible to reliably increase DFS 5-year by 7.4% and OS 5-year by 11.6%.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11038-11038
Author(s):  
B. Alonso ◽  
R. Aleman ◽  
L. Rodríguez ◽  
M. Llanos ◽  
J. Cruz ◽  
...  

11038 Background: Adjuvant therapies shown survival improve of non-metastatic breast cancer (NMBC) patients, but they also decrease bone mineral density (BMD). Bisphosphonates are effective agents for the management of osteoporosis. Intravenous zoledronate, which is approved for the treatment of malignant hypercalcemia, multiple myeloma, and skeletal metastases, can suppress bone resorption and are often considered first-line therapy for the treatment of osteoporosis. We have analyzed the effects of chemotherapy on BMD of women with NMBC who received before adjuvant therapies intravenous bisphosphonates (zoledronic acid). Methods: We prospectively studied the effects of a single intravenous zoledronic acid dose (4 mg), on BMD of 74 women with NMBC (stage I-III), administred previous to the adjuvant therapies. The patients were referred to the Medical Oncology Service of University Hospital of Canary Islands between 2003 y 2006. Lumbar and hip BMD (g/cm2) was measured at diagnosis and after chemotherapy. The results were compared with a group of 80 patients with NMBC who received adjuvant therapy without intravenous bisphosphonates. Results: Breast cancer patients the median age was 52 ± 10 years old and the body mass index was 28,2 ± 5.5 kg/m2. At baseline there were not differences in BMD between the group that received bisphosphonates and the group with only chemotherapy at any of lumbar or femoral bone sites. In our study, the BMD after chemotherapy and intravenous bisphosphonates (n=74) significantly increased at femoral neck (0.805 ± 0.01, 0,826± 0.12; p=0.002) and trochanter (0.709 ± 0.01, 0.724 ± 0.01; p=0.002) and remained stable at lumbar, intertrochanter, total hip and Ward’s triangle; whether the group without bisphosphonates significantly decreased at lumbar (1.014 ± 0; 0.995 ± 0, p=0.0001), trochanter (0.701± 0; 0.690 ± 0, p=0,046), intertrochanter (1,095 ± 0; 1.078 ± 0, p=0.0001) and total hip (0,924 ± 0; 0.915 ± 0, p=0.046) areas (table). Conclusions: Women with NMBC are affected by early bone loss after adjuvant chemotherapy. Bisphosphonates intravenous (zoledronic acid) given before adjuvant therapy might be an effective treatment for this bone loss, increasing BMD or remaining stable. No significant financial relationships to disclose.


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